Kornimate/medical-research-clean huggingface dataset:
phase i study of immune ablation and cd34+ peripheral blood stem cell support in patients with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: objectives: i. determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte globulin followed by peripheral blood stem cell support in patients with systemic lupus erythematosus.

protocol outline: patients receive cyclophosphamide iv over 1 hour for 2 doses. patients receive filgrastim (g-csf) subcutaneously (sc) beginning 24 hours after completion of cyclophosphamide and continuing until leukapheresis is complete. leukapheresis continues daily until target number of cells is harvested. cd 34+ cells are isolated from peripheral blood stem cells (pbsc) in vitro. patients then receive cyclophosphamide iv over 1 hour on days -5 to -2, anti-thymocyte globulin iv over 10 hours on days -4 to -2, and g-csf sc beginning on day 0 and continuing until blood counts recover. patients undergo reinfusion of cd34+ pbsc on day 0. patients are followed weekly for 90 days, monthly for 1 year, and at 2 years.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of systemic lupus erythematosus with 1 of the following malignant features: * nephritis (who class iii or iv) * failed nih short-course cyclophosphamide therapy * vasculitis/immune complex deposition causing end organ signs or symptoms (e.g., cerebritis, transverse myelitis, pulmonary hemorrhage, cardiac failure, or renal failure) * hematologic cytopenias that are immune mediated and uncontrolled by conservative measures with any of the following: transfusion-dependent anemia with untransfused hemoglobin less than 8 g/dl platelet count less than 40,000/mm3 (without transfusions) granulocyte count less than 1,000/mm3 catastrophic anti-phospholipid syndrome --patient characteristics-- cardiovascular: * lvef at least 35% * no lupus-induced myocarditis * no history of unstable angina pulmonary: * fev1/fvc at least 50% predicted * dlco at least 50% predicted other: * hiv negative * no prior or concurrent malignancy except localized basal cell or squamous cell skin cancer * no uncontrolled diabetes mellitus * no medical illness that would preclude study * no psychiatric illness or mental deficiency that would preclude study * no known hypersensitivity to e. coli-derived proteins * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception

Keywords: arthritis & connective tissue diseases immunologic disorders and infectious disorders rare disease systemic lupus erythematosus
novatears® eye drops observational study nt-002

Conditions: Dry Eye Syndromes

Summary: this observational study is intended to collect outcome data from a cohort of 90 patients suffering from symptoms of dry eye disease due to meibomian gland dysfunction who are treated with the medical device novatears® eye drops for a duration of 6 to 8 weeks.


Eligibility criteria:
inclusion criteria: * according to novatears® instruction for use * ≥ 18 years * patients with dry eye disease due to meibomian gland dysfunction applying eye lid hygiene for at least 14 days * ability and willingness to provide written informed consent * ability and willingness to participate in all examinations * willingness and ability to return for follow up visit exclusion criteria: * patients with hypersensitivity to any of the components of novatears® * patients with contact lenses, pregnancies, or who are breast feeding * patients with dry eye disease not caused by meibomian gland dysfunction * patients taking lipid containing eye drops or requiring topical pharmacological treatment of dry eye disease
a one-week crossover dispensing evaluation of new daily wear soft contact lenses

Conditions: Myopia

Summary: the purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon a (control).

the purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 1 week compared to nelfilcon a (control). the primary outcomes of interest is lens fit acceptance.

Eligibility criteria:
inclusion criteria: * is at least 18 years of age and has full legal capacity to volunteer. * is no greater than 55 years of age. * has read and understood the information consent letter. * is willing and able to follow instructions and maintain the appointment schedule. * is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study. * has spectacle cylinder ≤1.00d in both eyes. * has spherical contact lens power requirement between -1.00d and -6.00d in both eyes. * has manifest refraction visual acuities (va) equal to or better than logmar equivalent of 20/25 in each eye. * wears cls in both eyes (monvision acceptable, but not monofit) * has clear corneas and no active ocular disease. * has not worn lenses for at least 12 hours before the examination. * is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week exclusion criteria: * has never worn contact lenses before. * has any systemic disease affecting ocular health. * is using any systemic or topical medications that will affect ocular health. * has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * is aphakic. * has strabismus/amblyopia. * has undergone corneal refractive surgery. * is pregnant, lactating or planning a pregnancy. * is participating in any concurrent clinical or research study.
selections of subjects with important changes in their cardiac repolarization parameters for the procurement of skin and blood samples

Conditions: Cardiology: RR / QT

Summary: the study main objective is to assess the changes in the ventricular repolarization (measure by the delta qtcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples.

an ecg is performed after a dose of sotalol on about 100 healthy subjects in order to identify about 20 extreme responders (10 high responders and 10 non responders) assessed as delta qtcf compare to baseline. the ecg will be measured and the delta qtcf will be calculated on the 20 selected subjects in a second part of the clinical trial, cross over erythromycin/placebo.

Eligibility criteria:
inclusion criteria: * 18 to 40 years of age * caucasian origin * bmi 19 to 29 kg/m² * informed consent obtained * national health security number * eligible for phase i as mentioned in the national registry of healthy volunteers * for woman: use of an effective contraceptive method non inclusion criteria: * asthma * heart rate \< 50 bpm * hypotension with systolic blood pressure\< 100 mm hg. * atrioventricular block (pr interval \> 200 ms) * known chronic illness (hepatic, renal or cardiac impairment, etc..) * raynaud's phenomenon * drug known to prolong qt (http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm) in the last 7 days. * all chronic treatments are forbidden exceptive : oral contraceptives, paracetamol, vitamins and comfort treatment that do not prolong the qt * known family or individual past history of qt prolongation or unexplained syncope * (qtcf) \> 450 ms * qrs interval non assessable on ecg at rest or bundle-branch block, qrs \> 100 ms * allergy to macrolide type antibiotics * known allergy to sotalol or lidocaine * positive blood pregnancy test (inclusion visit) * known abnormal haemostasis * kaliemia\< 3.5 mmol/l * magnesemia\< 0,7 mmol/l * under exclusion period or participating to another clinical trial on a new medicinal product * creatinin clearance \< 80 ml/min (cockroft and gault formula) * ast-alt \>3x upper normal limit

Keywords: drug induced qt prolongation
coping with glioblastoma: a study of communication between physicians, patients, and caregivers

Conditions: Brain Cancer; Glioblastoma

Summary: the purpose of this study is to learn more about the way physicians communicate with brain tumor patients. this study will look at how oncologists provide information about brain tumors, brain scan results, and treatment options. this study will look at how oncologists provide information about brain tumors, brain scan results, and treatment options. ultimately, the investigators hope to use these findings to improve communication between patients, caregivers and their doctors.


Eligibility criteria:
inclusion criteria: patient inclusion criteria: * 18 years or older * pathologic diagnosis of who grade iv glioma, as per mskcc medical record or outside medical record. * in the judgment of the consenting professional, proficiency in english that will allow the participant to be able to complete study questionnaires and assessments. many of the study assessments are available only in english. * at the time of consent, orientation to self, place, month and year caregiver inclusion criteria: * 18 years or older * identified by the patient as a relative, friend, or partner with whom he or she has a significant relationship and who provides him or her informal (unpaid) care (i.e., physical or emotional assistance). * in the judgment of the consenting professional, proficiency in english that will allow to complete study questionnaires and assessments. many of the study assessments are available only in english. oncologist inclusion criteria: * treating neuro-oncologist in the department of neurology exclusion criteria: patient exclusion criteria: * a patient will be excluded if in the opinion of his/her attending neuro-oncologist or the covering neuro-oncologist, he does not have the capacity to consent to the study based on clinical evaluation * aphasia precluding comprehension and verbalization of consent to participate, in the estimation of the attending physician. caregiver exclusion criteria: * there are no caregiver exclusion criteria.

Keywords: communication physicians patients caregivers 15-034
proton beam therapy to treat esophageal cancer

Conditions: Esophageal Squamous Cell Carcinoma; Adenocarcinoma Of Esophagus

Summary: assess progression-free survival and overall survival of proton beam therapy (pbt) for patients with resectable vs. unresectable esophageal cancer, and to assess patient-reported outcomes of pbt for esophageal cancer at 6 months following chemoradiation and physician-reported toxicity of pbt for esophageal cancer.


Eligibility criteria:
inclusion criteria: * histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach. * staged by pet/ct and esophagogastroduodenoscopy (egd) or ct w/contrast and egd to have stage ii or iii disease. endoscopic ultrasound (eus) is encouraged but not required. * prior endoscopic mucosal resection (emr) with a diagnosis of stage ii or iii esophageal cancer is eligible, irrespective of margin status. * induction chemotherapy prior to concurrent chemoradiation is allowed. * prior thoracic radiation is allowable if degree of overlap with the esophageal radiotherapy treatment is deemed to be safe by the treating radiation oncologist. * at least 18 years of age. * ecog performance status ≤ 2 (karnofsky \> 60%) * normal bone marrow and organ function as defined below: * wbc \> 2,500/mcl * platelets ≥ 75,000/mcl * total bilirubin ≤ 1.5 x iuln * ast(sgot)/alt(sgpt) ≤ 3.0 x iuln * creatinine ≤1.5 x iuln or creatinine clearance ≥ 50 ml/min/1.73 m2 for patients with creatinine levels above institutional normal * women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * ability to understand and willingness to sign an irb approved written informed consent document. * english speaker. * financial coverage for proton therapy. exclusion criteria: * planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone. * previous or concomitant cancers within the past 3 years other than curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, curative treatment for transitional cell carcinoma of the bladder, and low risk prostate cancer. except for prostate cancer (which can be observed if low risk), other cancers listed must have been treated in the past 3 years without evidence of recurrence at the time of registration. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia not controlled by pacer device, myocardial infarction within 3 months of registration, or psychiatric illness/social situations that would limit compliance with study requirements * pregnant and/or breastfeeding. patient must have a negative pregnancy test within 7 days of study entry.
ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non-cf be)

Conditions: Bronchiectasis

Summary: the purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

number of participants with adverse events will be covered in adverse events section. the statistical analysis tests for the efficacy variables will be performed hierarchically. the comparisons ciprofloxacin dpi vs. pooled placebo (according to statistical analysis plan defined for fda registration) will be performed in parallel for the regimen 28 days on/off and 14 days on/off.

Eligibility criteria:
inclusion criteria: * patients with a proven and documented diagnosis of non cystic fibrosis (cf) idiopathic or post infectious bronchiectasis * stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks exclusion criteria: * forced expiratory volume in 1 second (fev1) \ 90% predicted * active allergic bronchopulmonary aspergillosis * active and actively treated non tuberculosis mycobacterial (ntm) infection or tuberculosis * primary diagnosis of chronic obstructive pulmonary disease (copd)

Keywords: ciprofloxacin dry powder for inhalation exacerbation bronchiectasis
understanding liver fat metabolism: studies to understand the role of dietary sugars on liver fat metabolism

Conditions: Hypertriglyceridaemia

Summary: high levels of fatty substances in the blood increase the risk of developing coronary heart disease and having a heart attack. the investigators know a lot about one of these fatty substances, cholesterol. however, there is another fatty substance in the blood called triglyceride. the investigators do not understand much about what regulates the rate at which the liver produces triglyceride and liberates it into the bloodstream after eating a meal(s). the investigators are developing new techniques to measure these processes in healthy people. ultimately a deeper understanding of the regulation of this process might lead to the development of new treatments for fat accumulation in the liver and high blood fat levels and related disorders. the present study is an investigation of how these processes relate to various bodily characteristics such as thinness and fatness and the distribution of fat in the body.

the investigators will recruit men and women with no medical condition or relevant drug therapy that affects lipid, glucose or liver metabolism. purpose and design: the investigators are asking the research question: "how does the amount and type of sugars consumed, such as those found in soft drinks, influence postprandial fatty acid and liver fat metabolism?" it is known that consuming fructose by itself or with glucose can increase plasma triglyceride concentrations and liver fat amounts but it remains unclear how this happens. to address this research question investigators want to undertake detail physiological studies, in a randomised cross-over study where individuals will be studied twice after the consumption of a single test meal that will contain different amounts of glucose and fructose with the same amount of dietary fat.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * bmi \>19 \<35kg/m2 * no medical condition or relevant drug therapy known to affect liver, lipid or glucose metabolism exclusion criteria: * age \ 65 years * body mass index \ 35kg/m2 * a blood haemoglobin \<120mg/dl * any metabolic condition or relevant drug therapy * people who do not tolerate fructose * smoking * history of alcoholism or a greater than recommended alcohol intake * pregnant or nursing mothers * women prescribed any contraceptive agent or device including oral contraceptives, hormone replacement therapy (hrt) or who have used these within the last 12 months * history of severe claustrophobia * presence of metallic implants, pacemaker * haemorrhagic disorders * anticoagulant treatment

Keywords: triglycerides glucose fructose fatty acids
identification of undiagnosed gaucher disease

Conditions: Gaucher Disease

Summary: partners healthcare maintains a patient data registry (pdr) with information from all patient encounters at partners healthcare facilities. we intend to utilize the pdr to identify groups of patient who are of high clinical suspicion for undiagnosed gaucher disease. a group of potential participants will be identified through the pdr. detailed records will be requested to further narrow to ideal participants based upon previously existing diagnoses and symptoms. participants will be invited to partake in the study via a letter from their partners care provider with supporting study details. study participants will be evaluated in a one-time visit. a complete family and medical history will be collected. a physical exam will be performed, and up to 20cc of blood will be drawn. all participants will be notified of their disease status via letter and phone call from the study staff. if the study participant is diagnosed with gd through this evaluation, proper follow-up recommendations and referrals will be provided. our intent is to determine if existing patient data can successfully be utilized to aid in the identification of patients with rare genetic disease.


Eligibility criteria:
inclusion criteria: * must have records available in the partners healthcare patient data registry exclusion criteria: * must not have a diagnosis of gaucher disease

Keywords: gaucher disease lysosomal storage disorder metabolic disease medical records review
mitigating ptsd-cud after sexual assault

Conditions: Posttraumatic Stress Disorder; Cannabis Use Disorder

Summary: 683,000 women are sexually assaulted annually in the united states, half of whom develop chronic posttraumatic stress disorder (ptsd) and thus have markedly increased risk for cannabis use disorder (cud). the current proposal will test the acceptability, initial efficacy, and mechanisms underlying a novel digital therapeutic targeting risk for ptsd-cud, which could address the critical need for ptsd-cud prevention for the 100,000 women who annually present for emergency care after sexual assault. in this research context, the applicant will receive key training in multisite, emergency-care based randomized clinical trials (rcts), advanced statistical analyses for rcts and ecological momentary assessment data, biobehavioral mechanisms underlying ptsd-cud prevention, and professional development, launching her independent research career focused on reducing the public health burden of ptsd-cud among sexual assault survivors by leveraging digital therapeutics.


Eligibility criteria:
inclusion criteria: 1. women sexual assault survivors presenting for emergency care \<72 hours post-assault at 1 of our 4 emergency care sites 2. english speakers 3. 18+ years of age 4. able to provide informed consent 5. have a smartphone with continuous service \>1 year 6. report \>1x/weekly cannabis use on a substance use screener 7. report elevated as (\>17 on the anxiety sensitivity index-3) exclusion criteria: 1. inability to provide informed consent (e.g., serious injury preventing the ability to hear, speak, or see to consent and participate, or other causes (e.g., diagnosed cognitive deficits, diagnosed dementia, asleep at time of screening)). 2. prisoner 3. currently pregnant 4. lives with assailant and plans to continue to do so 5. admitted patient 6. no mailing address 7. previously enrolled 8. no sexual assault nurse examiner (sane) examination 9. reporting current plan and intent for suicide or homicide 10. does not understand written and spoken english
a study to evaluate safety and efficacy of karxt + karx-ec as a treatment for psychosis associated with alzheimer's disease (adept-5)

Conditions: Alzheimer Disease; Psychosis

Summary: the purpose of this study is to evaluate karxt + karx-ec as a treatment for psychosis associated with alzheimer's disease.


Eligibility criteria:
inclusion criteria: * participants must be 55 to 90 years of age, inclusive, at the time of screening (visit 1). * participants must be diagnosed with alzheimer's disease in accordance with the 2024 nia-aa criteria. * participants must have a magnetic resonance imaging (mri) or computed tomography (ct) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (cns) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma. * participants must have a history of psychotic symptoms (meeting international psychogeriatric association criteria) for at least 2 months prior to screening (visit 1) (participants may or may not have symptoms of agitation). exclusion criteria: * participants must not have psychotic symptoms that are primarily attributable to a condition other than the ad causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features. * participants must not have history of major depressive episode with psychotic features during the 12 months prior to screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder. * participants must not have certain safety concerns, including certain laboratory test irregularities. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: alzheimer disease alzheimer dementia psychosis